医药导报2023，Vol.42Issue(12)：1785-1790,6.DOI:10.3870/j.issn.1004-0781.2023.12.007
氯巴占片在中国健康成年受试者中的生物等效性研究
Bioequivalence Study of Clobazam Tablet in Chinese Healthy Subjects
张学农 1王燕燕 1李莉娥 2张敏 2宋俐萍 2易梦娟 2吴先迪 1游辉1
作者信息
- 1. 三峡大学第一临床医学院·宜昌市中心人民医院药学部,宜昌 443003
- 2. 宜昌人福药业有限责任公司,宜昌 443003
- 折叠
摘要
Abstract
Objective To study the pharmacokinetic characteristics of clobazam tablet in Chinese healthy subjects and evaluate the bioequivalence of test preparation(T)and reference preparation(R)under fasting or fed conditions.Methods A randomized,open-label,single-dose,two-period,two-way crossover bioequivalence trial was performed.34 healthy subjects were enrolled in fasting study and 30 in fed study.Each subjects received a single dose of T 20 mg or R 20 mg with a washout period of 28 days.Plasma concentrations of clobazam and its active metabolite,N-desmethylclobazam were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS).The pharmacokinetic parameters of clobazam and N-desmethylclobazam were calculated by non-compartment model.Geometric mean values for the T/R ratios of clobazam's main pharmacokinetic parameters and their corresponding 90 percent confidence intervals(CI)were evaluated to assess bioequivalence of the two preparations.Results In fasting study,the 90 percent CI of the geometric mean values for the T/R ratios were 94.46 to 103.82 percent for Cmax,99.64 to 103.62 percent for AUC0-tand 99.39 to 103.51 percent for AUC0-∞,respectively.In fed study,the 90 percent CI of the geometric mean values for the T/R ratios of were 93.86 to 106.02 percent for Cmax,100.37 to 104.51 percent for AUC0-tand 100.71 to 104.63 percent for AUC0-∞,respectively.Conclusion In this study,the 90 percent CI of the geometric mean values of Cmax,AUC0-tand AUC0-∞ for T/R ratios were all within the acceptable bioequivalence limits of 80 to 125 percent for clobazam.Therefore two formulations were considered bioequivalent.关键词
氯巴占/药动学/生物等效性Key words
Clobazam/Pharmacokinetics/Bioequivalence分类
医药卫生引用本文复制引用
张学农,王燕燕,李莉娥,张敏,宋俐萍,易梦娟,吴先迪,游辉..氯巴占片在中国健康成年受试者中的生物等效性研究[J].医药导报,2023,42(12):1785-1790,6.
